Device for Producing High Pressure in a Fluid in Miniature

ABSTRACT

A miniaturized device for pressurizing fluid. The device includes a hollow piston that provides a fluid path and a valve member. The valve member is configured for axial movement so that the valve axis remains parallel to the piston axis. The valve member is arranged at one end of the hollow piston. The valve member may be partially or completely disposed within the hollow piston. The device is particularly adapted for use in a mechanically operated atomizer to produce an inhalable aerosol of a liquid medicament without the use of propellant gas.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.11/165,496, filed Jun. 24, 2005; which is a continuation of U.S.application Ser. No. 10/807,447, filed Mar. 24, 2004, now U.S. Pat. No.6,918,547; which is a continuation of U.S. application Ser. No.10/292,470, filed Nov. 13, 2002, now U.S. Pat. No. 6,726,124; which is acontinuation of U.S. application Ser. No. 10/143,006, filed May 13,2002, now U.S. Pat. No. 6,497,373; which is a continuation of U.S.application Ser. No. 09/354,663, filed Jul. 16, 1999, now U.S. Pat. No.6,402,055; which is a division of U.S. application Ser. No. 08/726,219,filed Oct. 4, 1996, now U.S. Pat. No. 5,964,416. The disclosures of theabove-referenced applications are incorporated by reference herein intheir entirety.

BACKGROUND OF THE INVENTION

The invention relates to a device for producing high pressure in afluid. It comprises a piston which is movable in a cylinder, and avalve, both preferably of miniaturised construction. The inventionfurther relates to a high pressure atomiser which contains this device,and the use thereof, preferably for medicinal purposes.

One aim of the invention is to enable a device of this kind and theatomiser containing the device to be made simpler in design and cheaperto produce and suited to its function.

In liquid chromatography (HPLC), for example, generally relatively smallquantities of liquid are conveyed at high pressure through theseparating column. Moreover, in medicinal aerosol therapy, aerosols areobtained, by atomising or nebulising liquid drugs for treating diseasesof the respiratory tract in humans or for treating asthmatic conditions.Here again, a high pressure is required in a, generally relativelysmall, quantity of fluid in order to produce the small droplet sizeneeded for the aerosol. In the metered dose inhaler according to U.S.Pat. No. 5,497,944, (the entire contents of which are incorporatedherein by reference) a predetermined volume of a fluid is sprayedthrough a nozzle with a small aperture under a pressure of between 5 and40 MPa (about 50 to 400 bar) to produce an aerosol. The presentinvention is particularly applicable to such metered dose inhalers andsimilar devices.

BRIEF SUMMARY OF THE INVENTION

According to one aspect of the invention there is provided a device,preferably of miniaturised construction, for producing high pressure ina fluid, comprising a piston which is movable in a cylinder, a highpressure chamber which is located in front of the piston inside thecylinder, and a valve, which device includes

a cylindrical hollow piston,

a valve member which is guided by the hollow piston and is mounted so asto be axially movable against the hollow piston,

a stop means on the hollow piston which holds the valve member to thehollow piston and

a defined (predetermined) sealing surface at the inlet end of the valvemember, the valve member generally being restrained from rotation aboutany axis transverse to the piston axis.

According to another aspect of the invention, there is provided a devicefor producing high pressure in a fluid, preferably of miniaturisedconstruction, comprising a cylinder, a hollow cylindrical piston whichis movable in the cylinder and provides a path for fluid therethrough, ahigh pressure chamber which is located in front of the piston inside thecylinder and which is supplied with fluid through said path, and aninlet valve in said fluid path which moves with the piston but is alsocapable of limited guided movement along the piston axis between aclosed position in contact with a valve seat provided by the piston andan open position spaced from the valve seat, the valve member being soshaped and guided that it cannot rotate about any axis transverse to thepiston axis such that a predetermined surface thereof engages the seat.

In U.S. Pat. No. 5,497,944, there is described and shown a similardevice in which the check valve member is a ball. With such anarrangement, the ball can rotate during multiple operations. It has beenfound that wear and distortion under the high pressure involved canpermanently deform the ball so that if a different part of its surfaceis used during sequential closing and sealing operations (because theball is free to rotate about a transverse axis) there is a tendency forleakage to occur. This can be avoided by using the same surface of thevalve member each time thus allowing bedding down to ensure the desiredseal. In the preferred arrangement according to the invention, at leasta major part of the valve member is cylindrical and is guided in achamber (which may, for example, be the pump chamber itself or may bepart of the interior of the piston) and the valve member cylinder has anend surface which co-operates with the valve seal provided by thepiston. Another disadvantage of a ball valve which can be avoided usingthe invention is that the transverse area of the valve is necessarilyconsiderably smaller than the diameter of the ball and thus the guidecylinder in which it moves; this leads to a reduction in the forceapplied by the valve member to the valve seat arising from fluidpressure generated during the pressure stroke (forward movement) of thepiston. A high application force of the valve member is desirable toslightly elastically deform the valve member and/or the valve seat toclose any slight gaps between them.

In the specification which follows, the terms inlet and outlet side orinlet and outlet end are used in relation to the main direction of flowof the fluid within the device. The term fluid includes both gases andliquids but the present invention is mainly concerned with liquids.

The valve member is somewhat displaceable against the hollow piston butit moves substantially with the hollow piston.

The valve member is preferably uniaxially rotationally symmetrical inshape, e.g. it is a circular cylinder or a frustum. Its cross-section issomewhat smaller than the cross-section of the chamber in which thevalve member is movably mounted. This is achieved by means of one ormore channels preferably extending in the outer surface of thecylindrical valve member, or by a somewhat smaller diameter of the valvemember in relation to the diameter of the chamber in which the valvemember is movably mounted.

The valve member is guided in the chamber in which it is movablymounted; a cylindrical valve member can rotate about its axis asrequired, but its axis always remains parallel to the axis of the hollowpiston. This produces a defined sealing surface at the inlet end of thevalve member.

The distance over which the valve member can travel relative to thehollow piston is limited by a stop or stop means which holds the movablevalve member together with the hollow piston.

In some embodiments of the invention wherein the stop is beyond theoutlet end of the valve member, there may need to be at least one recessin the region of the outlet end of the valve member to enable the fluidto flow through between the stop and the valve member when the valve isopen. Each recess is located either in the valve member at the outletend thereof or in the stop in the hollow piston.

In the position where the valve member abuts on the stop of the hollowpiston, the valve is opened. In the position where the valve memberabuts on the defined sealing surface, the valve is closed.

A valve member arranged inside the hollow piston has virtually nofriction against the inner wall of the hollow piston. A valve memberarranged directly in front of the end of the hollow piston may possiblyrub against the wall of the main pump cylinder of the device. In thiscase, the valve is actively closed and opened as the hollow pistonmoves, on account of the friction between the valve member and thecylinder wall.

The cylinder preferably consists of plastics and the hollow piston ofmetal or plastics. The material for the valve member is selected, interms of its hardness, to complement the hardness of the material forthe hollow piston and may be metal, ceramics, glass, gemstone, plasticsor elastomer. The valve member is preferably manufactured in one piece.

When the fluid is sucked in, the high pressure chamber is connected tothe fluid supply by means of the hollow piston. During the intake strokeof the hollow piston the fluid flows through the hollow piston and pastthe valve member into the high pressure chamber of the cylinder. Duringthe exhaust stroke of the hollow piston the valve seat is sealed in ahigh pressure tight manner against the defined sealing surface of thevalve member.

The device according to the invention for producing high pressure in afluid is connected to the fluid supply at its inlet end. The highpressure chamber is connected to another device into which or throughwhich the fluid is conveyed under high pressure. The hollow piston orthe cylinder is attached to a drive which brings about relative movementbetween the hollow piston and cylinder and which applies the forcerequired to generate the high pressure.

In the first embodiment, the cylindrical valve member may be guided andmounted in an axially movable manner directly in front of the end of thehollow piston, the diameter of the valve member being substantiallyequal to the internal diameter of the cylinder. On the outside, near itsoutlet end, the hollow piston has an encircling, preferably turned orshaped groove as a stop member, into which a plurality of snap hooks onthe valve member engage. Instead of the groove, the hollow piston mayhave at its outlet end a shaped taper with an encircling, outwardlyfunnel-shaped edge. The outer diameter of the hollow piston at itsoutlet end is greater than the base diameter of the groove and less thanthe diameter of the cylinder. Instead of the encircling groove, theoutlet end of the hollow piston may be provided on the outside, atseveral, preferably two diametrically opposed points, with flattenedareas which form a step to act as a stop means. The flat end of thehollow piston provides a valve seat cooperating with a defined flatsealing surface on the inlet side of the valve member. The outer edge atthe end of the hollow piston may be chamfered.

In the second embodiment, the cylindrical valve member may be guided andmovably mounted directly in front of the end of the hollow piston, thediameter of the valve member being substantially equal to the internaldiameter of the cylinder. The end of the hollow piston is shapedinwardly to provide an interned lip and acts as a stop means. On thevalve member is mounted a coaxial, undercut, mushroom-shaped peg thesnap hooks of which engage behind the shaped edge of the hollow piston.The defined sealing surface which extends around the peg rests on theoutlet end of the piston on the edge of the lip.

In the third embodiment, the preferably cylindrical valve member may bemounted so as to be fully movable inside the hollow piston. The outletend of the hollow piston has an internal diameter greater than theinternal diameter of the remainder of the hollow piston. The length ofthis widened portion of the hollow piston is somewhat greater than thelength of the valve member. The diameter of the valve member issubstantially equal to the inner diameter at the widened end of thehollow piston. The outlet end of the hollow piston is shaped inwardly toform a lip either over its entire periphery or over a part of itsperiphery and acts as a stop which holds the valve member inside thehollow piston. The base of the widened portion which forms the valveseat may be flat or conical. A fluid flow recess in the outlet side thevalve member may, for example, take the form of a stepped channel. Afluid flow recess in the stop may be constructed, for example, as anindentation in the lip edge.

In a variant of this embodiment, the valve member may be arrangedtotally inside the hollow piston at the inlet end thereof. The stop willthen be located at the outlet end of the widened portion and the definedsealing surface will then be on the shaped edge at the inlet end of thehollow piston.

In the fourth embodiment, the hollow piston consists of a thin-walledtube which is shaped at its end projecting into the cylinder and isprovided with an encircling constriction at the end of the space allowedfor the valve member. The cylindrical valve member is guided and movablymounted in the space between the shaped edge and the encirclingconstriction. Another thick-walled tube may be pushed into the inlet endof the hollow piston, its outer diameter being equal to the innerdiameter of the hollow piston, and this thick-walled tube further beingfixedly connected to the hollow piston and preferably extendingapproximately up to the encircling constriction in the hollow piston.The thick-walled tube acts as a displacement member and makes it easierfor the fluid to be sucked into the high pressure chamber virtuallywithout pressure being applied. The thick-walled tube is preferably madeof plastics.

In a variant of this embodiment, the valve member may be mounted fullyinside the hollow piston at the inlet end thereof. The stop is thenlocated at the encircling constriction and the defined sealing surfaceis located at the shaped edge at the inlet end of the hollow piston.

In the fifth embodiment, the hollow piston comprises a thin-walled tubewhich contains a thick-walled tube the outer diameter of which is equalto the inner diameter of the hollow piston, and which is fixedlyconnected to the hollow piston. The thick-walled tube functions as adisplacement body and makes it easier for the fluid to be sucked invirtually without pressure being applied.

The inlet end of the hollow piston is widened. At the widened end, thehollow piston is fixedly connected to a closure member the outerdiameter of which is greater than the outer diameter of the widenedinlet end of the hollow piston. The closure member contains a depressionwhich is open on its side facing the widened end of the hollow piston.In the base of the depression is an opening acting as an inlet for thefluid. The base of the depression may be conical or flat; it forms thedefined sealing surface.

The valve member is arranged in the depression in the closure member; itis guided so as to be axially movable in the depression. The externaldiameter of the valve member is smaller than the internal diameter ofthe depression, but preferably greater than the internal diameter of thehollow piston in that part of it which projects into the cylinder. Thevalve member may contain, at its outlet end, at least one recess throughwhich the fluid flows into the high pressure chamber during the intakestroke of the hollow piston.

The stop for the valve member is preferably the end of the displacementbody which projects into the widened portion of the hollow piston, or—ifthe end of the displacement body is located in the unwidened portion ofthe hollow piston—the transition from the unwidened portion of thehollow piston into the widened inlet end thereof.

The hollow piston with the widened inlet end preferably consists ofmetal. The displacement body and closure member are preferably made ofplastics. The valve member may be made of plastics or metal.

Of particular significance is the use of the device according to theinvention for producing high pressure in a fluid in an atomiser(nebulizer) for propellant-free spraying of the fluid.

According to another aspect of the invention, there is provided anatomiser for spraying a fluid, consisting of an upper housing part, apump housing, a nozzle, a blocking mechanism, a spring housing, a springand a supply container, characterised by

a pump housing fixed in the upper housing part which has at one end anozzle member with the nozzle, a hollow piston with valve member,

a drive flange in which the hollow piston is secured and which islocated in the upper housing part,

a blocking mechanism located in the upper housing part,

a spring housing with the spring located therein, which is rotatablymounted by means of a rotary bearing on the upper housing part,

a lower housing part which is fitted onto the spring housing in theaxial direction.

Other aspects of the invention are set out in the independent claims butvariations and combinations of particular features therein can be madewithout departing from the scope of the invention. Certain preferredfeatures are defined in the subclaims.

Further preferred features of the atomiser will now be described. Theatomiser is preferably a metered dose inhaler.

The hollow piston with valve member preferably corresponds to one of thedevices according to the invention mentioned hereinbefore. It projectspartially into the cylinder of the pump housing and is mounted inaxially movable manner in the cylinder. The hollow piston with valvemember exerts a pressure of 5 to 60 MPa (about 50 to 600 bar),preferably 10 to 60 MPa (about 100 to 600 bar) on the fluid at its highpressure end at the moment of release of the spring.

The nozzle in the nozzle member is preferably microstructured, i.e.produced by microtechnology. Microstructured nozzle members aredisclosed, for example, in U.S. Pat. No. 5,472,143, the entire contentsof which are incorporated herein by reference.

The nozzle member consists, for example, of two plates of glass and/orsilicon firmly joined together, of which at least one plate has one ormore microstructured channels which connect the nozzle inlet end to thenozzle outlet end. At the nozzle outlet end is at least one circular ornon-circular opening less than or equal to 10 μm in size. Size in thisconnection refers to hydraulic diameter. Hydraulic diameters in thistype of apparatus are generally less than 100 micrometres preferably1-20 micrometres.

The directions of spraying of the nozzles in the nozzle member may runparallel to one another or may be inclined relative to one another. In anozzle member having at least two nozzle openings at the outlet end, thedirections of spray may be inclined relative to one another at an anglefrom 20 to 160°, preferably at an angle from 60 to 150°. The directionsof spraying meet in the vicinity of the nozzle openings.

In the pump housing, a non-return valve with or without spring bias maybe provided between the nozzle opening and the high pressure chamber ofthe cylinder. This non-return valve closes off the high pressure chamberin the resting state of the atomiser; protects the fluid from theentrance of air and may if necessary prevent volatile components of thefluid from evaporating out of the pump housing. The non-return valveopens automatically as soon as the pressure of the fluid in the highpressure chamber exceeds a minimum value and the current of fluid iscreated; it closes automatically as soon as the current of fluid isexhausted. The non-return valve may be, for example, a ball valve. Itmay also consist of a flexible plate which is clamped on one side andrests like a flap on the outlet end of the high pressure chamber. Inanother embodiment it may consist of a disk of preferably flexiblematerial, clamped all the way round, pierced by a pin. The pierced holeallows the current of fluid to pass through to the nozzle as soon as thepressure in the fluid exceeds a minimum value. After the current offluid is exhausted, the pin hole closes up again.

The valve member is preferably mounted at the end of the cylinder facingthe nozzle member. The blocking or latching mechanism has a spring,preferably a cylindrical helical compression spring, as a store formechanical energy. The spring acts on the driven flange as a jumpingmember the movement of which is determined by the position of a blockingmember. The path of travel of the driven flange is precisely defined byan upper and lower stop. The spring is preferably tensioned by anexternal torque via a force stepping-up device, e.g., a helical sawtooththrust cam, the force being generated as the upper housing part rotatescounter to the spring housing in the lower housing part. In this case,the upper housing part and the driven flange comprise a single ormultiple sawtooth wedge arrangement.

Mechanisms of this general type are disclosed in U.S. Pat. No. 4,260,082and GB Application 2291135 the entire contents of both of which areincorporated herein by reference.

The blocking member with engaging blocking surfaces is arranged in anannular configuration around the driven flange. It consists, forexample, of a plastics or metal ring which in one form is inherentlyradially resiliently deformable. The ring is arranged in a plane atright angles to the atomiser axis. After the biasing of the spring, theblocking surfaces of the blocking member move into the path of thedriven flange and prevent the spring from being released. The blockingmember is actuated by a button. The actuating button is connected orcoupled to the blocking member. In order to actuate the blockingmechanism the actuating button is pushed parallel to the plane of thering, preferably into the atomiser; the deformable ring is therebydeformed in the plane of the ring to release the flange for movement bythe spring.

The preferred blocking member and spring are described and shown inGerman Patent Application 195452267 and filed by Microparts but assignedto Boehringer Ingelheim International GmbH. The entire contents of thisapplication is incorporated herein by reference.

The atomiser optionally contains a mechanical counter comprising a screwthreaded spindle which is mounted on the spring housing. The axis of thespindle extends in the region of the outer surface parallel to the axisof the atomiser. The spindle is mounted, in the region of its ends, bymeans of a rotary bearing on the spring housing. The spindle has teethat the end closest to the upper housing part. On the edge of the upperhousing part is at least one cam which engages in the teeth at the endof the spindle when the two housing parts are rotated relative to oneanother. A slider with rotation prevention means is mounted on thespindle and engages its threads.

The preferred counter is described and shown in German PatentApplication 195 49 033.9 dated 28 Dec. 1995 and filed by Microparts butassigned to Boehringer Ingelheim International GmbH. The entire contentsof this application is incorporated herein by reference.

The lower housing part is pushed axially over the spring housing andcovers the mounting, the drive of the spindle and the storage containerfor the fluid. The position of the slider is visible through a recess inthe lower housing part and can be read off on a scale, e.g., on thelower housing part.

When the atomiser is actuated the upper housing part is rotated relativeto the lower housing part, the lower housing part carrying the springhousing with it. The spring meanwhile is compressed and biased by meansof the helical thrust cam, and the blocking mechanism engagesautomatically. The angle of rotation is preferably a whole-numberfraction of 360°, e.g., 180°. At the same time as the spring is biased,the driven part in the upper housing part is moved a certain distance,the hollow piston is retracted inside the cylinder in the pump housing,as a result of which some of the fluid is sucked out of the storagecontainer into the high pressure chamber in front of the nozzle.

By means of the gears, which consist of a piston on one end of thespindle and a rack or racks on the edge of the upper housing part, therelative movement of the two housing parts is picked up and convertedinto a rotary movement of the spindle and displacement of the slider onthe spindle. On each actuation of the atomiser, the slider is moved acertain distance along the spindle.

The position of the slider indicates what proportion of the fluid to beatomised has already been taken from the storage container and how muchis still available. The slider on the spindle can be reset if necessaryby means of a resetting lug.

If desired, a plurality of (preferably collapsible) replaceable storagecontainers holding the fluid which is to be atomised can be insertedinto the atomiser one after another and used. The storage container isnot pressurised or substantially not pressurised. The pressure of thefluid in the storage container is in any case substantially lower thanthe pressure generated in the high pressure chamber by the mechanicallyoperated atomiser. The storage container contains, for example, a fluidcontaining a drug.

A suitable container with a dimensionally stable outer part and an innerpart collapsible as the liquid therein is removed as disclosed in U.S.Pat. No. 5,316,135, the entire contents of which are incorporated hereinby reference.

The atomising process is started by gently pressing the actuatingbutton. The blocking mechanism then opens up a path for the driven partto move. The biased spring pushes the piston into the cylinder of thepump housing. The fluid leaves the nozzle of the atomiser in spray form.

The components of the atomiser are made of a material which is suitablefor the function. The housing of the atomiser and, insofar as functionallows, other parts are preferably made of plastics, e.g., by injectionmoulding. For medicinal purposes, physiologically acceptable materialsare used.

The atomiser according to the invention is used, for example, forpropellant-free production of medicinal aerosols. An inhalable aerosolwith a mass average particle (droplet) size of about 5 μm can beproduced thereby. These small particles (average size less than 12 μm)are necessary for penetration right down into the lungs. The amountdischarged is preferably about 15 microlitres.

The following active substances are mentioned by way of example ofpharmaceutical compositions in the form of aqueous or ethanolicsolutions, depending on the solubility of the active substance: berotec,berodual, flunisolide, atrovent, salbutamol, budesonide, combivent,tiotropium, oxivent and suitable peptides.

The solutions may also contain pharmaceutically acceptable excipients.

The preferred device according to the invention for producing highpressure in a fluid and the preferred atomiser containing this devicehave the following advantages:

-   -   The device contains a valve which operates without any auxiliary        force (produced by a spring) and closes as a result of the flow        resistance of the fluid on the valve member or as a result of        the friction on the cylinder wall.    -   The valve is tight against a pressure generally above 3 MPa (30        bar).    -   The valve member is made in one piece; it is easy to manufacture        and assemble.    -   The valve closes very rapidly owing to the short distance        travelled by the valve member to reach the defined sealing        surface.    -   The valve has a high sealing action.    -   As a result of the guiding of the uniaxially rotationally        symmetrical valve member, a defined sealing surface is produced        which is high pressure tight through a very large number of        cycles of movement of the hollow piston.    -   The dead space of the high pressure chamber can be kept        extremely small.    -   The atomiser can be operated safely and easily even by untrained        persons, both to bias the spring and to actuate the atomising        process.    -   The atomiser works without propellant gas and is therefore        environmentally friendly.    -   The storage container for the fluid is not pressurised or        substantially not pressurised.    -   The movement of the blocking member is automatically coupled, by        a simple method, to the rotary movement for biasing the spring.        In a preferred embodiment the atomiser consists of low-wear        purely mechanical components and operates reliably over long        periods.    -   Owing to the defined abutments for the driven part the metering        of the fluid is very accurate.    -   The atomiser can be manufactured cheaply and assembled easily.    -   The mechanical counter is automatically advanced as the atomiser        is actuated; it is uncritical of tolerance, easy to assemble and        operates safely and reliably.    -   The counter is inaccessible when the atomiser is used properly        and cannot be falsified by accident.    -   The counter can be adapted to any number of releases of fluid        from the storage container and to different overall numbers of        storage containers to be used with one atomiser.    -   The counter is integrated in the atomiser and does not take up        any additional space.    -   No substances can pass from the counter into the substance which        is to be atomised.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention will now be described by way ofexample with reference to the drawings in which:

FIGS. 1 a, 1 b and 1 c are respectively a longitudinal section of afirst embodiment of a pump for producing high pressure in a fluidaccording to the invention, an oblique view of its hollow piston and anoblique view of its valve member;

FIGS. 2 a, 2 b and 2 c are similar views of a second embodiment; FIGS. 3a, 3 b and 3 c are similar views of a third embodiment; FIGS. 4 a, 4 band 4 c are similar views of a fourth embodiment;

FIGS. 4 d, 4 e and 4 f are similar views of a modification of the fourthembodiment;

FIG. 5 is a longitudinal section of a fifth embodiment; and

FIGS. 6 a and 6 b are longitudinal cross-sections of a metered doseinhaler according to the invention in different operative conditions.

FIG. 7 shows a storage container comprising a collapsible inner portionand a stable outer portion.

DETAILED DESCRIPTION OF THE INVENTION

The various embodiments of the pump device have already been describedabove in general terms but these descriptions will now be supplementedwith further description with reference to the drawings.

FIG. 1 a shows a longitudinal section, viewed obliquely, through thefirst embodiment of the device according to the invention for producinghigh pressure in a fluid. In the cylinder (1) is the hollow piston (2)with the coaxial bore (7) and the valve member (3) in the partly openposition of the valve. Between the bottom of the valve member (3) andthe end of the cylinder is the high pressure chamber (4). The highpressure chamber is closed off by another component (not shown). Mountedon the hollow piston, outside the cylinder, is a device (not shown) bymeans of which the hollow piston can be displaced inside the cylinder.

FIG. 1 b shows the hollow piston (2) viewed obliquely. The end of thehollow piston facing the valve member is provided with a groove (5)which is bounded, at its end facing the valve member, by a rectangularsection annular land forming a step (8) the diameter of which is lessthan the external diameter of the hollow piston (2) and greater than thebase diameter of the groove. The front edge at the end of the hollowpiston may be chamfered.

FIG. 1 c shows the valve member (3) viewed obliquely. It has, forexample, three channels (9) on its outer surface to facilitate fluidflow when the valve is open. Mounted on the valve member (3), on itsside facing the hollow piston, are, for example, three snap hooks (6)the width of which, in the direction of the circumference of the valvemember, is less than a third of this circumference. The snap hooks (6)are shorter in the axial direction than the length of the, for example,grooved end of the hollow piston.

During assembly, the valve member (3) is placed on the end of the hollowpiston (2), and the hooks (10) slide into the groove. The hollow pistontogether with the valve member is then pushed into the cylinder.

When the valve is open, the inner edge of the hooks (10) abut on thestep (8). When the valve is closed, the base of the valve member (3)facing the hollow piston fits tightly on the end of the hollow piston(2) which acts as the defined sealing surface.

In order to take in the fluid, the hollow piston is lifted partly out ofthe cylinder, whereupon the valve automatically opens. The fluid flowsthrough the bore (7) in the hollow piston and past the valve member intothe high pressure chamber (4). In order to expel the fluid, the hollowpiston (2) is pushed into the cylinder (1), whereupon the valve closesautomatically, virtually instantly, and high pressure is generated inthe fluid.

FIG. 2 a shows the second embodiment of the device according to theinvention for producing high pressure in a fluid as a longitudinalsection viewed obliquely. In the cylinder (1) is the hollow piston (11)and the valve member (13) in the partly open position of the valve.

FIG. 2 b shows a longitudinal section through the hollow piston (11)with the shaped outlet end (12) of the hollow piston. A displacementbody (26) may be fixedly located in the hollow piston.

FIG. 2 c shows the valve member (13) as a longitudinal section viewedobliquely. Mounted on the valve member is a coaxial, undercut peg (14)the projecting end of which engages behind the shaped edge (12) of thehollow piston. The end (15) of the peg facing the hollow piston may bechamfered. The peg may have an indentation or bore (16) extending in theaxial direction and possibly longitudinal slots extending upwards fromthe end (15) thus forming snap hooks so that the peg can be pushed intothe shaped end of the hollow piston, thereby engaging behind the shapededge.

FIG. 3 a shows the third embodiment of the device according to theinvention for producing high pressure in a fluid in longitudinal sectionviewed obliquely. In the cylinder (1) is the hollow piston (17) and thevalve member (18) in the closed position of the valve.

FIG. 3 b shows a longitudinal section viewed obliquely through thehollow piston (17) with the shaped end (19). At the outlet end of thehollow piston is the widened portion (20) in which the valve member (18)is guided and mounted in axially movable manner. The inlet end of thewidened portion (20) is chamfered or flat.

FIG. 3 c shows the cylindrical valve member (18) in longitudinal sectionviewed obliquely. Both ends of the valve member are planar and arelocated perpendicularly to the axis of the valve member. The valvemember (18) contains, for example, four stepped channels or flats (21)on its outer surface to facilitate fluid flow past the shaped end (19),i.e. the inturned lip, when the valve is open, the ends of the channels(21) being radially inward of the lip. The edge of the valve member (18)which abuts on the inclined base of the hollow chamber (20) may bechamfered.

The diameter of the valve member (18) is less than the diameter of thewidened portion (20) so that the valve member (18) can move virtuallywithout friction in the widened portion (20).

For assembly, the valve member (18) is pushed into the widened portion(20) before the outlet end (19) of the hollow piston is shaped.

FIG. 4 a shows the fourth embodiment of the device according to theinvention for producing high pressure in a fluid in longitudinal sectionviewed obliquely. In the cylinder (1) are the hollow piston (22) and thevalve member (23) in the closed position of the valve. The diameter ofthe valve member is less than the inner diameter of the hollow piston.

FIG. 4 b shows a longitudinal section, viewed obliquely, through thehollow piston (22) with the shaped outlet end (24) forming an inturnedlip and the encircling constriction (25). The thick-walled tube (26)acting as the displacement body may be pushed into the hollow piston(22) and secured therein.

FIG. 4 c shows the valve member (23) in oblique view. At the outlet endof the valve member is a radially extending indentation (27) in the formof a transverse slot to facilitate fluid flow when the valve is open.

FIG. 4 d shows an alternative to the fourth embodiment in longitudinalsection, viewed obliquely. In the cylinder (1) is the hollow piston(28), optionally with the displacement body (26), with the valve in theclosed position. The diameter of the valve member (29) is less than theinternal diameter of the hollow piston.

FIG. 4 e shows a longitudinal section, viewed obliquely, through thehollow piston (28) with the shaped outlet end (24) and the encirclingconstriction (25). At least one indentation (30) in the form of a recessor notch is provided on the shaped outlet end (24) to facilitate fluidflow when the valve is open. Instead of the indentation there may be aconvexity.

FIG. 4 f shows the valve member (29) in oblique view. In this case, thevalve member is a straight cylinder with no recesses.

FIG. 5 shows the fifth embodiment of the device according to theinvention for producing high pressure in a fluid, in longitudinalsection and viewed obliquely. In the cylinder (1) is the hollow piston(31) which contains the displacement body (32). Mounted on thecylindrically widened inlet end (33) of the hollow piston is the closuremember (34) with the depression (35) and bore (36). In the indentationis the guided, axially movable valve member (37) which may be providedat its outlet end with a slot (38) as recess.

The embodiments of the device according to the invention for producinghigh pressure in a fluid shown in FIGS. 2 a to 5 work in the same way ashas already been explained with reference to FIG. 1 a.

FIG. 6 a shows a longitudinal section through the preferred atomiserdescribed in detail above with the spring biased and FIG. 6 b shows alongitudinal section through the atomiser with the spring released.

The upper housing part (51) contains the pump housing (52) on the end ofwhich is mounted the holder (53) for the atomiser nozzle. This holder ispreferably as described in German Patent Application P19536303.3-51 of 4Oct. 1995 (and a parallel PCT application being filed simultaneouslyherewith in the joint names of Boehringer Ingelheim International GmbHand the inventors) the entire contents of which are incorporated hereinby reference. In the holder is the nozzle member (54) and a filter (55).The hollow piston (57) fixed in the cup-shaped drive flange (56) of theblocking mechanism (62) partly projects into the cylinder of the pumphousing. At its end the hollow piston carries the valve member (58). Thehollow piston is sealed off by the seal (59). Inside the upper housingpart is the annular abutment (opposite annular ridge (60) on the flange)on which the flange rests when the spring is released. On the axial endof the cup-shaped driven flange is the abutment (61) by which the drivenflange is held when the spring is biased. After the biasing of thespring, the generally annular blocking member (62) moves between theabutment (61) and a support (63) in the upper housing part, eitherbecause of its own elasticity or (when it is more rigid) by virtue of anexternal spring (not shown). The actuating button (64) is connected tothe blocking member and can either move it bodily or deform it so thatit releases the abutment (61). The upper housing part terminates in themouth piece (65) and is closed off by the protective cap (66) which canbe fitted thereon.

The spring housing (67) with compression spring (68) is rotatablymounted on the upper housing part by means of the snapping lug (69) androtary bearing. The lower housing part (70) is pushed over the springhousing and rotates with it to operate the helical sawtooth cam drive(not shown) for cocking the atomiser (moving it from the FIG. 6 bposition to the FIG. 6 a condition). Inside the spring housing is thereplaceable storage container (71) for the fluid (72) which is to beatomised. The storage container is fitted with a stopper (73) throughwhich the hollow piston projects into the storage container and dips itsend into the fluid.

Mounted in the outer surface of the spring housing is the spindle (74)for the mechanical counter. At the end of the spindle facing the upperhousing part is the drive pinion (75). The slider (76) sits on thespindle.

An example of a suitable container is taken from the disclosure of U.S.Pat. No. 5,316,135, and is shown in FIG. 7. As described in U.S. Pat.No. 5,316,135, the storage container has a collapsible inner portion 7and a stable outer portion 5. Outer portion 5 is a dimensionally stableouter container. Inner portion 7 is an easily deformable inner bag. Amore complete description of the container shown in FIG. 7 may be foundin U.S. Pat. No. 5,316,135.

The embodiments shown in the drawings may be varied further. Thecomponents may be used together in a manner other than that shown in thedrawings.

EXAMPLE 1 Miniaturised Device for Producing High Pressure for aMedicinal Atomiser

The valve area of a medicinal atomiser according to FIG. 1 a consists ofa cylinder made of polybutylene-terephthalate with an internal diameterof 1.6 mm and an external diameter of 5 mm. The high pressure chamber isclosed off by a nozzle carrier plate. In this plate is a nozzle 20 μm indiameter and the nozzle channel is 2 mm long.

A metal hollow piston with an external diameter of 1.59 mm and a bore0.35 mm in diameter is pushed into the cylinder. The hollow piston canbe pushed 50 mm into the cylinder and its-stroke is 12 mm long. Thehollow piston has an encircling turned groove 4 mm wide with a basediameter of 0.75 mm. The groove is bounded by a 4.0 mm long step with adiameter 1.15 mm. The outer edge of the turned end of the hollow pistonis chamfered.

The valve member made of polybutyleneterephthalate consists of a 2 mmthick disk 1.59 mm in diameter and 3 snap hooks. Three semi-cylindricalchannels 0.4 mm in diameter are provided as recesses on the outersurface of the disk. The snap hooks project 6 mm from the disk and theinner edge of the hooks is 4.2 mm away from the disk. The valve membermay thus be moved axially 0.2 mm relative to the hollow piston.

The delivery volume is 23.4 mm³. The pressure in the fluid is about 32MPa (320 bar).

This atomiser is used to atomise or nebulize liquid pharmaceuticals formedicinal aerosol therapy. The atomiser delivers the drug in therequired dose on each actuation.

EXAMPLE 2 Miniaturised Device for Producing High Pressure for a CosmeticAtomiser

The valve area of a cosmetic atomiser corresponding to FIG. 3 a consistsof a cylinder of polyetherether-ketone with an internal diameter of 2.5mm and an outer diameter of 8 mm. The high pressure chamber is closedoff by a nozzle carrier plate. In this plate is a nozzle 25 μm indiameter with a nozzle channel 2 mm long.

A hollow piston. of reinforced plastics with an external diameter of2.48 mm and a bore 0.5 mm in diameter is pushed into the cylinder. Thehollow piston can be pushed 45 mm into the cylinder and its stroke is 24mm. The hollow piston is drilled out to an internal diameter of 1.85 mmover a length of 5.0 mm at its outlet end. The base of the drilled-outchamber in the hollow piston is chamfered. The outlet end of the hollowpiston is thermally deformed.

The valve member is a cylinder of polypropylene which is 3.0 mm high and1.6 mm in diameter. Four stepped channels are provided as recesses inthe outer surface. The valve member can be displaced axially about 0.5mm inside the hollow piston.

The delivery volume is about 116 mm³. The pressure in the fluid is about3 MPa (30 bar).

This atomiser is used to atomise a hair spray.

1. A replaceable unit for use with an atomizer, comprising within ahousing a device for producing high pressure in a fluid, said devicecomprising a hollow piston capable of being moved axially within thehousing as well as the replaceable unit for holding a supply of fluid tobe atomized, said replaceable unit being substantially not pressurizedand being free from propellants, wherein: the replaceable unit comprisesa dimensionally stable outer portion with a collapsible portion disposedwithin said outer portion, and a stopper firmly coupled to both thedimensionally stable outer portion and to the collapsible inner portionof the replaceable unit, and said stopper defines a bore through whichthe hollow piston of the atomizer projects so that fluid to be atomizedcan be withdrawn from a storage container, and the replaceable unit isarranged within the housing of the atomizer and is firmly put on thehollow piston in a way such that the replaceable unit moves to and frotogether with the hollow piston within the housing when the atomizer isoperated.
 2. The replaceable unit of claim 1, wherein said storagecontainer comprises a pharmaceutical composition.
 3. The replaceableunit of claim 1, wherein said storage container comprises apharmaceutically acceptable solution of a medicament selected from thegroup consisting of berotec, berodual, flunisolide, atrovent,salbutamol, budesonide, combivent, tiotropium, oxivent, and suitablepeptides.